Spyre Therapeutics, Inc. announced that it has initiated dosing of healthy volunteers in its first clinical trial of SPY001, an investigational novel half-life extended anti-α4β7 monoclonal antibody.

"The Spyre team has executed efficiently to achieve this milestone within a year of our public launch. SPY001 is the first of our programs across three of the most impactful mechanisms in IBD, namely α4β7, TL1A, and IL-23, all of which are expected to enter the clinic within the next twelve months," said Cameron Turtle, D.Phil., Chief Executive Officer of Spyre. "We look forward to highlighting interim data for SPY001 by the end of this year, which we expect will confirm that SPY001 is well tolerated with a half-life that enables a convenient Q8-12W subcutaneous dosing schedule, with interim data for our T1LA program to follow."

The SPY001 Phase 1 trial is a double blind, placebo-controlled study in healthy volunteers and consists of a single-ascending dose (SAD) component and a multi-ascending dose (MAD) component. The study is expected to enroll approximately 48 healthy adult participants into four SAD cohorts and two MAD cohorts.

The primary endpoint is safety, with pharmacokinetics (PK) serving as a secondary endpoint. We expect interim safety and PK data from this trial by year-end 2024. Pending data from the Phase 1 trial, the company anticipates progressing into Phase 2 development with SPY001 in 2025.

"α4β7 inhibition is a preferred first-line treatment option among gastroenterologists given its favorable safety profile with a gut-selective mechanism of action and demonstrated efficacy superiority over TNF inhibition in the VARSITY study," said Deanna Nguyen, M.D., SVP of Clinical Development at Spyre. "We believe this unique safety and efficacy profile, combined with a more convenient dosing frequency, could make SPY001 an ideal backbone for combination therapy for IBD with the inhibition of other highly active mechanisms including T1LA and IL-23."